Status:
TERMINATED
Study of Acamprosate in Driving Under the Influence (DUI) Court Participants
Lead Sponsor:
University of Oklahoma
Collaborating Sponsors:
Forest Laboratories
Conditions:
Alcohol Dependence
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
Acamprosate will be given to approximately 30 DUI Court participants for 3 months and outcomes will be monitored. The hypothesis is that acamprosate will be safe and well-tolerated and that subjects' ...
Detailed Description
Purpose: The study is a 13 week open-label study of the use of acamprosate in subjects who have elected to participate in the DUI Court program in Tulsa County. Admission to the DUI Court is completel...
Eligibility Criteria
Inclusion
- Adult males and females age 18 - 64 years of age
- District Attorney-approved DUI Court participants within 3 months of enrollment into DUI Court
- Currently meets DSM-IV criteria for alcohol dependence
- Subject agrees to alcohol abstinence as a goal
- Women must agree to use an approved method of birth control (tubal ligation, birth control pills, IUD)
- Negative UCG (females only)
- Treatment with an MAOI, other antidepressants, antipsychotics, anticonvulsants, mood stabilizers, or Saint John's Wort are permissible if subject has been on a stable dose for 3 months
- Must have the ability to comprehend key components of the informed consent and provide consent
- Current score of 15 or less on the Beck Depression Inventory II
- Subject has undergone detoxification and is currently abstinent from alcohol
Exclusion
- History of allergy to acamprosate
- Previously failed trial of acamprosate
- Pregnancy, lactation, or unprotected intercourse during study period
- Lifetime diagnosis of schizophrenia or schizoaffective disorder
- Creatinine clearance \<30 mL/minute. If serum creatinine is greater than 1.4 mg/dL then the Cockcroft-Gault equation will be used to estimate creatinine clearance
- Active suicidality, a Beck Depression Inventory II suicide item score of \> 2, or a Beck Depression Inventory II total score \> 15
- Any unstable medical condition which, in the opinion of the investigator, is considered clinically significant or could affect the subject's safety or ability to complete the study
- Use of a benzodiazepine or other sedative-hypnotic agent (including kava kava or valerian), except for eszopiclone, zaleplon, or zolpidem \< 3 times weekly over the last 4 weeks
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00425711
Start Date
February 1 2007
End Date
December 1 2009
Last Update
July 27 2012
Active Locations (1)
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1
The University of Oklahoma, Tulsa
Tulsa, Oklahoma, United States, 74135